AKNEMYCIN 2 %w/w Ointment

Country: Ireland

Language: English

Source: HPRA (Health Products Regulatory Authority)

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Active ingredient:

ERYTHROMYCIN

Available from:

Crookes Healthcare Ltd

INN (International Name):

ERYTHROMYCIN

Dosage:

2 %w/w

Pharmaceutical form:

Ointment

Authorization status:

Withdrawn

Authorization date:

2006-11-01

Summary of Product characteristics

                                PART II
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Aknemycin Ointment, 2 % w/w
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Erythromycin 2% w/w.
For excipients, see 6.1.
3 PHARMACEUTICAL FORM
Ointment
A whitish coloured ointment.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
The management of acne vulgaris particularly of the papular or pustular type.
4.2 POSOLOGY AND METHOD OF ADMINISTRATION
Adults and the Elderly: Apply sparingly to the affected area once or twice daily after thorough cleansing.
Children: Not recommended.
4.3 CONTRAINDICATIONS
Hypersensitivity to any of the constituents.
4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE
Prolonged use of anti-infective may result in superinfection due to micro-organisms resistant to that anti-infective.
If there is no response within 6-8 weeks alternative measures should be considered.
Prolonged use is not recommended. A course should not normally exceed 6 months.
4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION
Concomitant use with other topical treatment should only be carried out with caution in view of possible cumulative
local adverse effects.
4.6 PREGNANCY AND LACTATION
Studies of use during pregnancy have not been conducted no statements on safety can be made.
It is recommended that the preparation should only be used with caution in lactating women who are breast feeding,
and on areas away from the chest.
IRISH MEDICINES BOARD
________________________________________________________________________________________________________________________
_Date Printed 28/07/2006_
_CRN 2026147_
_page number: 1_
4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES
None known.
4.8 UNDESIRABLE EFFECTS
Local irritation, erythema and dryness may occur. Diarrhoea has been reported rarely.
4.9 OVERDOSE
Unlikely as the
                                
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